Surgical fastening system and method for using the same

ABSTRACT

A surgical fastening system for attaching one piece of tissue to another piece of tissue. The system comprises a surgical fastener, an installation tool for deploying the surgical fastener in tissue, and a method for using the same.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.11/520,002 filed on Sep. 12, 2006 now U.S. Pat. No. 7,699,870 andentitled “Surgical Fastening System and Method for Using The Same”,which is a continuation of U.S. patent application Ser. No. 09/875,588filed on Jun. 6, 2001 (now U.S. Pat. No. 7,105,010) and entitled“Surgical Fastening System” which is a continuation of U.S. patentapplication Ser. No. 09/340,584 filed on Jun. 28, 1999 (now abandoned)and entitled “Surgical Fastening System and Method for Using The Same”,which is a continuation of U.S. patent application Ser. No. 09/174,814filed on Oct. 19, 1998 (now abandoned) and entitled “Surgical FasteningSystem and Method for Using The Same” which is a continuation of U.S.patent application Ser. No. 08/560,111 filed on Nov. 17, 1995 (now U.S.Pat. No. 5,827,298) and entitled “Surgical Fastening System and Methodfor Using The Same”, all of which are hereby incorporated by referencein its entirety.

FIELD OF THE INVENTION

This invention relates to surgical fastening systems in general, andmore particularly to surgical fastening systems of the sort comprisingtack-like fasteners for attaching one piece of tissue to another pieceof tissue.

BACKGROUND OF THE INVENTION

In many medical applications, it is necessary (or at least desirable) tofasten one piece of tissue to another piece of tissue.

In the case of soft tissue, this fastening is traditionally accomplishedby sewing the two pieces of tissue together using needle and suture.

Unfortunately, in certain situations it can be extremely difficult, oreven impossible, to suture two pieces of tissue together. In many casesthis is due to the natural constraints imposed by the patient'sanatomical structure. By way of example, it can be extremely difficultto suture meniscal cartilage, which is located within the interior ofthe knee joint. Unfortunately, this presents a serious problem, inasmuchas many injuries involve tears to the meniscal cartilage, and suturingwould provide an otherwise preferred manner of repair.

With this and other situations in mind, a variety of different surgicalfastening systems have been developed to replace, or at leastsupplement, conventional suturing.

See, for example, U.S. Pat. Nos. 3,716,058 (Tanner, Jr.); 4,532,926(O'Halla); 4,548,202 (Duncan); 4,635,637 (Schreiber); 4,669,473(Richards et al.); 4,873,976 (Schreiber); 4,884,572 (Bays et al.);4,895,148 (Bays et al.); 4,924,865 (Bays et al.); 4,976,715 (Bays etal.); 5,053,047 (Yoon); and 5,059,206 (Winters); French PatentPublication No. 2,573,647 (Catier); and Japanese Patent Publication No.58-160013.

See also, for example, U.S. Pat. Nos. 4,688,561 (Reese); 4,935,028(Drews); 5,013,316 (Goble et al.); 5,129,906 (Ross et al.); 5,246,441(Ross et al.); and 5,370,646 (Reese et al.).

Unfortunately, none of the prior art surgical fastening systems haveproven to be entirely satisfactory, for a wide variety of differentreasons. The inadequacy of prior art surgical fastening systems hasproven to be particularly significant with respect to repairing tears inmeniscal cartilage within the interior of the knee joint.

OBJECTS OF THE INVENTION

Accordingly, one object of the present invention is to provide a novelsurgical fastening system for attaching one piece of tissue to anotherpiece of tissue, wherein the novel surgical fastening system overcomesthe various deficiencies associated with prior art surgical fasteningsystems.

Another object of the present invention is to provide a novel surgicalfastener for attaching one piece of tissue to another piece of tissue.

Still another object of the present invention is to provide a novelinstallation tool for deploying the aforementioned surgical fastener intissue.

Yet another object of the present invention is to provide a novelsurgical fastening system which is particularly well suited for use inrepairing tears in meniscal cartilage.

And another object of the present invention is to provide a novelsurgical fastener which is particularly well suited for use in repairingtears in meniscal cartilage.

And still another object of the present invention is to provide a novelinstallation tool which is particularly well suited for use in deployingthe aforementioned surgical fastener in meniscal cartilage.

And yet another object of the present invention is to provide a novelmethod for fastening one piece of tissue to another piece of tissue.

And still another object of the present invention is to provide a novelmethod for repairing tears in meniscal cartilage.

SUMMARY OF THE INVENTION

These and other objects are addressed by the present invention, whichcomprises a surgical fastening system and a method for using the same.

The surgical fastening system generally comprises a novel surgicalfastener and a novel installation tool.

The novel surgical fastener generally comprises a solid shaft ofsubstantially uniform diameter having a distal end and a proximal end; abar at the proximal end of the shaft, the bar extending outwardly fromthe shaft; the distal end of the shaft being rounded and devoid of acutting edge and devoid of a penetration point; and a fin extendingoutwardly from the shaft proximate the distal end, the fin having adistal edge inclined outwardly and proximally from the shaft and aproximal edge inclined outwardly and proximally from the shaft.

The novel installation tool generally comprises an elongated inserterwhich includes a carrier portion, the carrier portion being adapted toretain the fastener and having at a distal end thereof a sharpened edge,the carrier portion having an open side from which extend end portionsof the fastener's bar and fin.

The surgical fastening system is generally used as follows. First, thesurgical fastener is fitted to the installation tool's carrier portionso that the end portions of the fastener's bar and fin protrude from thecarrier portion's open side. Then the installation tool is manipulatedso that its carrier portion and the surgical fastener are projected intotissue, until the protruding portion of the fastener's bar engages theouter surface of the tissue. Finally, the installation tool ismanipulated so that the installation tool's carrier portion is withdrawnfrom the tissue, whereupon the protruding portion of the fastener's finresists proximal movement of the fastener, causing the fastener to beleft in the tissue.

In order to facilitate initial handling of the surgical fastener andloading the fastener into the installation tool's carrier portion, thesurgical fastener may initially be connected to a grip by one or moretabs, and the surgical fastener and its associated grip may initially beloaded into a holder, with the fastener being accessible in the holderthrough an opening. Thereafter, the surgical fastener can be loaded intothe installation tool's carrier portion by inserting the distal end ofthe installation tool into the holder's opening, whereby the distal endof the installation tool will serially sever any tabs holding thesurgical fastener to the grip as the surgical fastener is simultaneouslyloaded into the installation tool's carrier portion. The installationtool and the surgical fastener can thereafter be withdrawn from theholder as a unit, ready for use in attaching one piece of tissue toanother piece of tissue.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other objects and features of the present invention will bemore fully disclosed or rendered obvious by the following detaileddescription of the preferred embodiments of the invention, which are tobe considered together with the accompanying drawings wherein likenumbers refer to like parts, and further wherein:

FIG. 1 is a side view of a surgical fastener formed in accordance withthe present invention;

FIG. 2 is a top view of the same surgical fastener;

FIG. 3 is a front end view of the same surgical fastener;

FIG. 4 is a partial side view, partially in section, of an installationtool formed in accordance with the present invention, with the viewhaving been taken along line 4-4 in FIG. 6;

FIG. 5 is a partial top view, partially in section, of the sameinstallation tool, with the view having been taken along line 5-5 inFIG. 6;

FIG. 6 is a front end view of the same installation tool;

FIG. 7 is a partial side view, partially in section, showing thesurgical fastener of FIGS. 1-3 loaded into the installation tool ofFIGS. 4-6;

FIG. 8 is a partial top view, partially in section, of the assemblyshown in FIG. 7;

FIG. 9 is a front end view of the assembly shown in FIGS. 7 and 8;

FIG. 10 is a schematic view showing the assembly of FIGS. 7-9approaching a tear located in a piece of meniscal cartilage;

FIG. 11 is a schematic view showing the assembly of FIGS. 7-9 spanningthe aforementioned tear;

FIG. 12 is a schematic view showing the surgical fastener of FIGS. 1-3holding the aforementioned tear closed as the fastener's associatedinstallation tool is withdrawn from the piece of meniscal cartilage;

FIG. 13 is side view of the same surgical fastener shown in FIGS. 1-3,wherein the fastener is shown attached to a grip by a pair of tabs;

FIG. 14 is a front end view of the same surgical fastener and itsassociated grip;

FIG. 15 is a side view of a holder for holding the surgical fastener andits associated grip prior to loading the surgical fastener into itsassociated installation tool;

FIG. 16 is a rear end view of the same holder, i.e., as seen from theright side in FIG. 15;

FIG. 17 is a side view of a second installation tool for deploying thesurgical fastener of the present invention, with this installation toolbeing shown with its inserter positioned in a first, retracted position;

FIG. 18 is a side view of the second installation tool, but with theinstallation tool being shown with its inserter positioned in a second,partially-extended position;

FIG. 19 is a side view of the second installation tool, but with theinstallation tool being shown with its inserter positioned in a third,fully-extended position;

FIG. 20 is a side view showing the surgical fastener and grip of FIGS.13 and 14 mounted in the holder of FIGS. 15 and 16, with selectedportions of the holder being shown broken away;

FIG. 21 is a side view of the same assembly as that shown in FIG. 20,except that the distal end of the second installation tool of FIGS.17-19 is shown positioned adjacent to the proximal end of the surgicalfastener, with the installation tool's inserter being positioned in itsfirst, retracted position in preparation for loading the surgicalfastener onto the inserter;

FIG. 22 is a side view of the same assembly as that shown in FIG. 21,except that the installation tool has had its inserter advanced from itsfirst, retracted position to its third, fully-extended position so as toload the surgical fastener onto the inserter;

FIG. 23 is a front end view showing the surgical fastener loaded ontothe second installation tool's inserter;

FIG. 24 is a side view of the same assembly as that shown in FIG. 22,except that the installation tool has had its inserter retracted fromits third, fully-extended position to its first, retracted position soas to carry the surgical fastener back into the interior of theinstallation tool;

FIG. 25 is a side view showing the second installation tool, carryingthe surgical fastener, approaching a tear located in a piece of meniscalcartilage, with the installation tool's inserter being positioned in itsfirst, retracted position so that the surgical fastener is fullywithdrawn into the interior of the installation tool;

FIG. 26 is a side view like that of FIG. 25, except that theinstallation tool's inserter has been advanced into its second,partially-extended position as the surgical fastener is inserted intothe piece of meniscal cartilage at the near side of the tear;

FIG. 27 is a side view like that of FIG. 26, except that theinstallation tool's inserter has been advanced into its third,fully-extended position as the surgical fastener is extended across thetear;

FIG. 28 is a side view showing the surgical fastener holding theaforementioned tear closed, with the installation tool having beenremoved from the surgical site;

FIG. 29 is a side view like that of FIG. 28, except showing threesurgical fasteners closing a tear in a piece of meniscal cartilage;

FIG. 30 is a side view of a second surgical fastener formed inaccordance with the present invention;

FIG. 31 is a side view of a third surgical fastener formed in accordancewith the present invention;

FIG. 32 is a side view of a fourth surgical fastener formed inaccordance with the present invention;

FIG. 33 is a side view of a fifth surgical fastener formed in accordancewith the present invention;

FIG. 34 is a side view of a sixth surgical fastener formed in accordancewith the present invention;

FIG. 35 is a side view showing the surgical fastener of FIG. 34attaching a piece of surgical mesh to a piece of tissue;

FIG. 36 is a perspective view showing the surgical fastener of FIG. 34attaching the piece of surgical mesh to the piece of tissue;

FIG. 37 is a partial side view showing the distal end of a thirdinstallation tool formed in accordance with the present invention;

FIG. 38 is a side view showing the distal end of the third installationtool, with the third installation tool having been rotated 90 degreesfrom the position shown in FIG. 37;

FIG. 39 is a partial side view, partially in section, of an assemblycomprising a seventh surgical fastener formed in accordance with thepresent invention and an installation tool for deploying the same;

FIG. 40 is a partial top view, partially in section, of the assemblyshown in FIG. 39;

FIG. 41 is a partial top view, partially in section, of an assemblycomprising an eighth surgical fastener formed in accordance with thepresent invention and an installation tool for deploying the same;

FIG. 42 is a side view showing the eighth surgical fastener of FIG. 41closing a tear in a piece of meniscal cartilage;

FIG. 43 is a side view of a ninth surgical fastener formed in accordancewith the present invention;

FIG. 44 is a side view of a tenth surgical fastener formed in accordancewith the present invention;

FIG. 45 is a front end view showing the tenth surgical fastener of FIG.44 being carried by an appropriate installation tool; and

FIG. 46 is a side view of an eleventh surgical fastener formed inaccordance with the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Looking first at FIGS. 1-3, there is shown a surgical fastener 5 whichis formed in accordance with the present invention. Surgical fastener 5comprises a shaft 10 extending along a longitudinal axis 15 and having atop surface 20, a bottom surface 25, a distal end surface 30 and aproximal end surface 35. Distal end surface 30 is formed so as to have ablunt configuration, devoid of a cutting edge and devoid of apenetration point. Preferably distal end surface 30 is formed so as tohave a substantially rounded configuration, for reasons which willhereinafter be disclosed in further detail. Proximal end surface 35 ispreferably also formed so as to have a rounded configuration, forreasons which will hereinafter be disclosed in further detail.

At least one fin 40 extends out of the fastener's top surface 20,adjacent to distal end surface 30. Each fin 40 is configured so as to(i) present the least possible resistance to tissue when the fastener isbeing passed, distal end first, through tissue, and (ii) present thegreatest possible resistance to tissue when the fin is being withdrawn,proximal end first, from tissue. To this end, each fin 40 generallyprojects radially outwardly, and longitudinally rearwardly, from shaft10. Preferably each fin 40 comprises a leading surface 45 and a trailingsurface 50, where leading surface 45 is disposed at a significantly moreacute angle to the shaft's longitudinal axis 15 than trailing surface50. By way of example, leading surface 45 might be disposed at a 30degree angle to the shaft's longitudinal axis 15, whereas trailingsurface 50 might be disposed at a 75 degree angle to the shaft'slongitudinal axis 15. Preferably leading surface 45 and trailing surface50 meet at a sharp point 55.

Surgical fastener 5 also comprises a bar 60 which projects radiallyoutwardly from the fastener's top surface 20, adjacent to proximal endsurface 35. Bar 60 is adapted to present the greatest possibleresistance to tissue when the fastener is being passed, distal endfirst, through tissue. To this end, bar 60 extends generally radiallyoutwardly from shaft 10, and comprises a distal surface 65 and aproximal surface 70. Preferably bar 60 leans slightly distally, in themanner shown in FIGS. 1 and 2, as will hereinafter be disclosed infurther detail. By way of example, bar 60 preferably extends at a 75degree angle to the shaft's longitudinal axis 15.

As seen in FIGS. 2 and 3, each fin 40 and the bar 60 is preferably sizedso as to have a width slightly less than the width of shaft 10, forreasons which will hereinafter be disclosed in further detail.Furthermore, as seen in FIG. 1, it is preferred that the fastener's bar60 sit higher above the fastener's top surface 20 than fins 40, forreasons which will hereinafter also be disclosed in further detail.

Surgical fastener 5 may be formed in a variety of different sizes,according to its intended use. By way of example, where surgicalfastener 5 is to be used to close a tear in a piece of meniscal tissue,surgical fastener 5 might be formed with the following dimensions:TABLE-US-00001 total length 10.0 mm barb height 2.0 mm bar height 2.5 mmshaft width 1.0 mm barb width 0.8 mm bar width 0.8 mm.

Surgical fastener 5 is formed out of a bio-compatible material, wherebyit may be installed in living tissue without causing adverse reaction.By way of example, surgical fastener 5 may be formed out of anon-absorbable bio-compatible material of the sort well known in theart, e.g., acetal or polyethylene. Alternatively, surgical fastener 5may be formed out of an absorbable bio-compatible material of the sortwell known in the art, e.g., polylactic acid (PLA) or polyglycolic acid(PGA) or polycaprolactone (PCL) or trimethylene carbonate (TMC) or ablend, mix or copolymer of these or the like.

Surgical fastener 5 may be manufactured by any manufacturing processconsistent with its composition. By way of example, but not limitation,where surgical fastener 5 is formed out of acetal or polyethylene, itmay be molded in a mold or stamped and formed from a large sheet.Alternatively, where surgical fastener 5 is formed out of PLA or PGA orPCL or TMC or a blend, mix or copolymer of these or the like, they maybe molded in a mold.

Looking next at FIGS. 4-6, there is shown an installation tool 75.Installation tool 75 comprises an inserter 80 extending along alongitudinal axis 85 and having a top surface 90 and a bottom surface95. The distal end of inserter 80 comprises a carrier portion 83 whichterminates in a sharp point 100. Preferably sharp point 100 is formed bysloping the inserter's distal end surface 101 (FIG. 4) at an angle of 30degrees relative to longitudinal axis 85.

The inserter's carrier portion 83 is adapted to carry surgical fastener5 for deployment of that fastener in tissue. More particularly, theinserter's carrier portion 83 comprises a recess 105 which is formed inthe distal end of inserter 80, extending proximally from sharp point100. Recess 105 provides a seat for surgical fastener 5 as willhereinafter be disclosed in further detail. To this end, recess 105defines a floor 110 and terminates at a shoulder 115. Preferably recess105 is created by forming a proximally-extending bore 120 (FIG. 6) inthe distal end of inserter 80, and then cutting a slot 125 (FIG. 6) inthe inserter's top surface 90. By forming slot 125 so that it has awidth slightly less than the diameter of bore 120 (FIG. 6), recess 105can be provided with a keyway-type configuration.

Looking next at FIGS. 7-9, surgical fastener 5 is intended to be seatedin the installation tool's carrier portion 83 prior to deployment of thefastener into tissue. More particularly, surgical fastener 5 is intendedto be backed into the installation tool's distal recess 105 so that thefastener's shaft 10 is received in the inserter's bore 120 and thefastener's fins 40 and bar 60 protrude out the top of inserter 80,through the inserter's slot 125. As seen in FIGS. 7 and 8, surgicalfastener 5 and installation tool 75 are sized so that when the surgicalfastener's proximal end surface 35 engages the installation tool'sshoulder 115, the surgical fastener's distal end surface 30 will sitcompletely within the inserter's bore 120, withdrawn from theinstallation tool's sharp point 100. Furthermore, as seen in FIG. 9,surgical fastener 5 and installation tool 75 are sized so that only thefastener's fins 40 and bar 60, and not its shaft 10, will be able toprotrude out through the shaft's top slot 125. This construction ensuresthat surgical fastener 5 can enter and exit the inserter's recess 105only via the distal end of the recess, adjacent to the installationtool's sharp point 100. Surgical fastener 5 and installation tool 75 arealso sized so that the surgical fastener will make a close sliding fitwith the walls of the inserter's recess 105, whereby the fastener willbe supported by the inserter, yet be able to move axially along recess105.

A handle (not shown) is attached to the proximal end of inserter 80 bywhich the installation tool may be grasped by a user. By way of example,but not limitation, a screwdriver sort of handle, or a pistol grip sortof handle, might be attached to the proximal end of the inserter.

It will be appreciated that the dimensions of installation tool 75 arecarefully coordinated with the dimensions of surgical fastener 5, andthat these dimensions may vary according to the fastener's intended use.By way of example, where surgical fastener 5 has a total length of 10mm, a barb height of 2 mm, a bar height of 2.5 mm, a shaft width of 1mm, a barb width of 0.8 mm and a bar width of 0.8 mm, installation tool75 might be formed with the following dimensions: TABLE-US-00002inserter height 1.5 mm inserter width 1.5 mm recess length (to point100) 10.5 mm slot width 0.85 mm bore diameter 1.1 mm.

Surgical fastener 5 and installation tool 75 can be used to fasten onepiece of tissue to another piece of tissue. By way of example, but notlimitation, surgical fastener 5 and installation tool 75 can be used toclose a tear in a piece of meniscal cartilage located within theinterior of a knee joint.

More particularly, and looking now at FIG. 10, surgical fastener 5 andinstallation tool 75 can be used to close a tear 130 formed in a pieceof meniscal cartilage 135 in the following manner.

First, surgical fastener 5 is loaded into installation tool 75 bybacking the fastener into the installation tool's recess 105 so that thefastener sits in the inserter in the manner shown in FIGS. 7-9. In thisarrangement, the only portions of surgical fastener 5 that protrude outof installation tool 75 are the upper portions of the fastener's fins 40and bar 60.

Next, the distal end of installation tool 75 is positioned on theproximal side of tear 130, with the inserter's sharp point 100 adjacentto the outer surface of meniscal cartilage 135. Then the inserter'ssharp point 100 is forced into the meniscal cartilage and across tear130 (FIG. 11). As this occurs, surgical fastener 5 is carried throughmeniscal tissue 135 by inserter 80. It should be appreciated thatsurgical fastener 5 passes through the meniscal tissue withoutappreciable hindrance since the portions of fins 40 protruding from theinserter's recess 105 are configured to slide easily through the tissuein a distal direction. Forward movement of inserter 80 and surgicalfastener 5 continues until the portion of the fastener bar 60 protrudingfrom the inserter's recess 105 engages the outer surface of meniscaltissue 135. This engagement inhibits further movement of the assemblyinto the cartilage, since bar 60 is configured so as to inhibit movementthrough tissue in a distal direction. In this respect it should beappreciated that this is particularly true inasmuch as bar 60 isoriented with a slight distal lean, so as to increase the bar'sresistance to distal movement through tissue. At this point the force ofthe fastener's bar 60, pressing against the outer surface of meniscalcartilage 135, will tend to close up tear 130 (FIG. 11).

Next, installation tool 75 is withdrawn from meniscal cartilage 135. Asthis occurs, the portions of the fastener's fins 40 protruding from theinserter's recess 105 catch on the meniscal cartilage disposed on thedistal side of tear 130. This causes surgical fastener 5 to remain inplace within meniscal cartilage 135 as the installation tool iswithdrawn from the cartilage. Surgical fastener 5 sits within meniscalcartilage 135, with the meniscal cartilage on the distal side of tear130 being prohibited from moving in a distal direction by the fastener'sfins 40, and with the meniscal cartilage on the proximal side of tear130 being prohibited from moving in a proximal direction by thefastener's bar 60. This effectively keeps tear 130 closed so as tofacilitate healing of the meniscal cartilage (FIG. 12).

It is to be appreciated that surgical fastener 5 is preferably sized soas to ensure that the fastener's distal end surface 30 is completelyburied within the receiving tissue. This will prevent the distal end ofthe surgical fastener from engaging, and possibly interfering with, anybodily structures which may lie on the far side of the receiving tissue.Thus, for the exemplary meniscal cartilage application discussed above,surgical fastener 5 would be sized so that its distal end surface 30 isburied within the meniscal cartilage 135 when the fastener's bar 60bears against the outer surface of the meniscal cartilage. As a result,the distal end of the fastener will be insulated from engagement withany bodily structures which may lie on the far side of the cartilage.

However, in this respect it is also to be appreciated that, even if thedistal end of surgical fastener 5 should inadvertently protrude from thefar side of the cartilage, the deliberately rounded configuration of thefastener's distal end surface 30 will permit it to gently engage anysuch bodily structures, without any adverse consequences to suchstructures. This is an extremely important feature and a major advanceover prior art fastening systems, which generally utilize surgicalfasteners having sharply pointed distal end structures. Thus the presentinvention can be used safely in many situations (e.g., joint surgery)where prior art fasteners cannot be used safely. In this respect it isalso to be appreciated that it is possible to provide surgical fastener5 with its aforementioned rounded distal end surface 30 inasmuch as thepresent invention relies on the installation tool's sharp point 100, andnot on the fastener's distal end surface 30, to open a way in thetissue.

Furthermore, inasmuch as it is the installation tool's sharp point 100which opens a way in the tissue for the fastener, and not the surgicalfastener's distal end surface 30, the fastener's shaft does not have tobe made particularly rigid. Rather, some or all of the surgicalfastener's shaft 10 can be made somewhat flexible, if desired, so longas the fastener's barbs 40 and bar 60 are given sufficient structuralsupport to permit them to maintain their orientation vis-a-vis thereceiving tissue. This is another extremely important feature andanother significant advantage over prior art fastening systems, whichgenerally require that a rigid shaft be provided to permit tissuepenetration.

It is also to be appreciated that inasmuch as surgical fastener 5 isformed with a rounded proximal surface 35, and inasmuch as thefastener's bar 60 is configured so as to lean slightly in a distaldirection, the proximal end of fastener 5 will present a non-obtrusivepresence on the surface of meniscal cartilage 135. As a result, theproximal end of the fastener will not pose a threat to any bodilystructures which may lie on the near side of the cartilage.

Since it is intended that surgical fastener 5 may be formed fairly small(e.g., a length of about 1 cm in the meniscal cartilage application), itis preferred that means be provided to facilitate handling of thefastener, both during manufacture of the fastener and during loading ofthe fastener into installation tool 75 or into some other installationtool formed in accordance with the present invention.

To this end, it is preferred that (i) a grip 140 (FIGS. 13 and 14) beprovided in association with surgical fastener 5, whereby the fastenercan be more easily manipulated during manufacture of the fastener, and(ii) a holder 145 (FIGS. 15 and 16) be provided for holding surgicalfastener 5 and its associated grip 140 prior to loading the surgicalfastener into its associated installation tool. In accordance with thepresent invention, a second installation tool 150 (FIGS. 17-19) is alsodisclosed for use in conjunction with surgical fastener 5, grip 140 andholder 145.

More particularly, and looking now at FIGS. 13 and 14, a surgicalfastener 5 is shown attached to a grip 140 via a pair of tabs 155. Grip140 essentially comprises a relatively large, generally rectangular massor plate 160 which, due to its relative size, is more easily manipulatedby hand than fastener 5. Thus, the provision of grip 140 will facilitatehandling of fastener 5 during manufacture of the fastener. Tabs 155extend between grip 140 and fastener 5. As seen in FIG. 14, tabs 155have a reduced thickness adjacent to fastener 5, so as to facilitateseparation of the fastener from the tabs, as will hereinafter bedisclosed in further detail. It is preferred that fastener 5, grip 140and tabs 155 all be formed at the same time, out of the same material,as part of a single complete assembly, e.g., by molding.

As noted above, the assembly shown in FIGS. 13 and 14 is preferably usedin conjunction with the holder 145 shown in FIGS. 15 and 16. Moreparticularly, it is envisioned that surgical fastener 5 and grip 140will be packaged in holder 145 at the time of manufacture, and thenremoved from the holder at the time that the fastener is to be used in asurgical procedure. To this end, holder 145 includes a first recess 165for accommodating shaft 10 of fastener 5, an adjacent opening 170 foraccommodating fins 40 and bar 60 of surgical fastener 5, and an adjacentopening 175 for accommodating grip 140 associated with fastener 5.Holder 145 also comprises an opening 180 for permitting an installationtool to enter holder 145 and to engage, and then withdraw, the surgicalfastener 5 from the holder, as will hereinafter be disclosed in furtherdetail. To this end, opening 180 communicates with both opening 165 andopening 170. A shoulder 185 is formed at the point where openings 165,170 and 180 meet. Preferably holder 145 is formed out of two minorhalves 145A and 145B (FIG. 16) so as to facilitate the manufacture ofholder 145 and the positioning of surgical fastener 5 and grip 140 inthe holder.

Looking next at FIGS. 17-19, a second installation tool 150 is shownwhich may be used in conjunction with the present invention.Installation tool 150 comprises an inserter 80 (FIGS. 18 and 19) similarto the inserter 80 disclosed above. Inserter 80 is slidably disposedwith an elongated tube 190. Tube 190 includes a distal end 195terminating in a distal end surface 200, and a proximal end 205. Distalend surface 190 is preferably flat, whereby tube 190 will present ablunt distal end. The proximal end 205 of tube 190 is connected to ahandle 210. Handle 210 includes a button 215 which is connected to theproximal end of inserter 80 via selected means of the sort well known inthe art (not shown) whereby button 215 may be used to position inserter80 in (i) a first retracted position, wherein the distal end of theinserter is withdrawn into the interior of tube 190 (FIG. 17), (ii) asecond, partially-extended position, wherein the inserter's sharp point100 and a portion of its recess 105 will be projected out of the distalend of the installation tool's tube 190 (FIG. 18), and (iii) a third,fully-extended position, wherein all of the inserter's recess 105 willbe projected out of the distal end of the installation tool's tube 190(FIG. 19). In addition to the foregoing, the installation tool's tube190 is sized so that it can accommodate a surgical fastener 5 carried byinserter 80. By way of example, where surgical fastener 5 and inserter80 have the exemplary dimensions recited previously, tube 190 might havethe following dimensions: TABLE-US-00003 tube inner diameter height 3.2mm tube inner diameter width 1.8 mm tube outer diameter height 3.7 mmtube outer diameter width 2.3 mm.

Thus it will be appreciated that when the installation tool's inserter80 is in (i) its first, retracted position (FIG. 17), a surgicalfastener 5 carried by the inserter's carrier portion 83 will be disposedcompletely within tube 190, (ii) its second, partially-extended position(FIG. 18), a surgical fastener 5 carried by the inserter's carrierportion 83 will have its fins 40 exposed out the distal end of tube 190but its bar 60 shielded within tube 190, and (iii) its third,fully-extended position (FIG. 19), a surgical fastener 5 carried by theinserter's carrier portion 83 will have its fins 40 and bar 60 exposedout the distal end of tube 190.

As seen in FIGS. 17-19, tube 190 is preferably bent slightly near itsdistal end 195, so as to facilitate deployment of surgical fastener 5.To this end, inserter 80 is formed so as to have sufficient flexibilityto permit it to move easily through this bend as the inserter is movedbetween its aforementioned first, second and third position (i.e., thepositions shown in FIGS. 17, 18 and 19, respectively). At the same time,however, inserter 80 is formed so as to have sufficient structuralintegrity to permit it to penetrate the receiving tissue, so as todeploy the surgical fastener in that tissue.

As noted above, the surgical fastener and grip assembly shown in FIGS.13 and 14 is intended to be positioned within holder 145 at the time ofmanufacture, and then the surgical fastener loaded into secondinstallation tool 150 at the time that the fastener is to be used in asurgical procedure.

More particularly, and looking next at FIG. 20, surgical fastener 5 andits associated grip 140 are intended to be positioned within holder 145at the time of manufacture so that the fastener's shaft 10 is disposedin holder opening 165, the fastener's fins 40 and bar 60 are disposed inholder opening 170, and grip 140 is disposed in holder opening 175. Asseen in FIG. 20, holder 145 is sized so that the proximal end offastener 5 protrudes slightly beyond the holder's shoulder 185 and intoholder opening 180.

Looking next at FIG. 21, surgical fastener 5 is intended to be loadedinto second installation tool 150 at the time that the fastener is to beused in a surgical procedure. More particularly, surgical fastener 5 isloaded into second installation tool 150 in the following manner.

First, installation tool 150 has its inserter 80 positioned in itsfirst, retracted position (FIG. 17). Then the distal end 195 of theinstallation tool is inserted into holder opening 180 until the tube'sdistal end surface 200 engages holder shoulder 185. At this point recess105 of the installation tool's inserter will be aligned with surgicalfastener 5.

Next, the installation tool's inserter 80 is advanced from its first,retracted position to its third, fully-extended position (FIG. 22). Asthis occurs, the inserter's sharp point 100 will sequentially engage andthen sever each of the tabs 155 holding surgical fastener 5 to grip 140,so as to free surgical fastener 5 from grip 140. At the same time thatthis occurs, the advancing inserter 80 will also envelope fastener 5 sothat the fastener will be loaded into the inserter's recess 105. It isto be appreciated that, as the inserter severs tabs 155 and picks upfastener 5 in recess 105, small nibs 155A (FIG. 23) of tabs 155 remainattached to the fastener's bottom surface 25. These small nibs 155A givefastener 5 a slight upward bias within recess 105 of inserter 80, so asto cause fastener 5 to make a snug fit within that recess.

Next, inserter 80 is withdrawn back into tube 190 (FIG. 24). As thisoccurs, surgical fastener 5 is carried away from grip 140, and into tube190, by the retreating inserter 80. Finally, installation tool 150 iswithdrawn from holder 145. At this point, surgical fastener 5 will beloaded in the installation tool's inserter 80, ready to be deployed intotissue.

Once surgical fastener 5 has been loaded into second installation tool150, the surgical fastener and the installation tool can be used tofasten one piece of tissue to another piece of tissue. By way ofexample, but not limitation, surgical fastener 5 and installation tool150 can be used to close a tear in a piece of meniscal cartilage.

More particularly, and looking now at FIG. 25, surgical fastener 5 andsecond installation tool 150 can be used to close a tear 130 formed in apiece of meniscal cartilage 135. This may be accomplished in thefollowing manner.

First, the distal end of installation tool 150 is positioned on theproximal side of tear 130, with the tube's distal end surface 200adjacent to the outer surface of the piece of meniscal cartilage 135(FIG. 25). At this point, the installation tool's inserter 80 will be inits first, retracted position, so that fastener 5 will be completelyencased in the installation tool's tube 190.

Next, the installation tool has its inserter 80 advanced into itssecond, partially-extended position, and the inserter's sharp point 100is forced into the meniscal cartilage and across tear 130 (FIG. 26). Asthis occurs, surgical fastener 5 is carried through meniscal tissue 135by inserter 80. As noted previously with respect to installation tool75, inserter 80 is able to pass into the meniscal cartilage withoutsignificant impedance, since the portions of the fastener's fins 40protruding from the inserter's recess 105 are configured to slide easilythrough the tissue in a distal direction. Forward movement of inserter80 continues until the tube's distal end surface 200 engages the outersurface of meniscal tissue 135.

Next, the installation tool's inserter 80 is advanced from its second,partially-extended position to its third, fully-extended position. Asthis occurs, the installation tool's distal end surface 200 is keptpressed against the outer surface of the meniscal cartilage, compressingthe tissue and thereby closing tear 130. Accordingly, the installationtool's inserter passes further into the tissue, until the fastener's bar60 engages the outer surface of the meniscal cartilage (FIG. 27). Atthis point, further movement of the assembly into the cartilage isprohibited, since bar 60 is configured so as to prohibit movementthrough tissue in a distal direction.

Next, the installation tool's inserter 80 is moved from its third,fully-extended position (FIG. 27) to its first, fully retractedposition. This causes the inserter to be withdrawn from meniscalcartilage 135. As this occurs, the portions of the fastener's fins 40protruding from the inserter's recess 105 catch on the meniscalcartilage disposed on the distal side of tear 130. This causes fastener5 to remain in place within meniscal cartilage 135 as the inserter isretracted back into the installation tool's tube 190. At the same time,the installation tool's distal end surface 200 is kept pressed tightlyagainst the near surface of the cartilage, whereby tear 130 in meniscalcartilage 135 is kept closed as the retreating inserter 80 is withdrawnfrom the cartilage. Fastener 5 remains in meniscal cartilage 135, withthe meniscal cartilage on the distal side of tear 130 being prohibitedfrom moving in a distal direction by the fastener's fins 40, and themeniscal cartilage on the proximal side of tear 130 being prohibitedfrom moving in a proximal direction by the fastener's bar 60. Thiseffectively keeps tear 130 closed so as to facilitate healing of themeniscal cartilage (FIG. 28). Installation tool 150, which has its sharpinserter 80 safely sheathed within its tube 190, may then be withdrawnfrom the surgical site.

It is anticipated that some situations (e.g., the situation shown inFIGS. 12 and 28), a single fastener 5 may be sufficient to effect thedesired tissue attachment. However, it is also anticipated that in othersituations (e.g., the situation shown in FIG. 29) multiple fasteners maybe used to effect the desired tissue attachment.

It is to be appreciated that the particular construction of installationtool 150 permits the installation tool to be moved to the surgical sitewhile its sharp inserter 80 is safely sheathed within blunt tube 190,and thereafter removed from the surgical site while its sharp inserter80 is safely sheathed within blunt tube 190. This is an importantfeature, particularly where the installation tool must be maneuveredaround delicate bodily structures on its way to, and away from, thesurgical site.

As disclosed above, surgical fastener 5 can be used to attach one pieceof tissue to another piece of tissue. This was illustrated above inconnection with closing a tear 130 in a piece of meniscal cartilage 135.However, it should also be appreciated that surgical fastener 5 can beused to effect many other types of tissue attachment. By way of furtherillustration, but not limitation, surgical fastener 5 might be used torepair a tear in a rotator cuff. Or surgical fastener 5 might be used toattach together other types of tissue, e.g., surgical fastener 5 mightbe used to attach skin to an underlying tissue structure, or it might beused in other types of plastic surgery, or it might be used to attachvascular tissue to an adjacent tissue structure, or it might be used toattach ocular tissue to an adjacent tissue structure. It is alsopossible to use surgical fastener 5 to attach a piece of “seed” tissueto an underlying tissue structure, where that “seed” tissue will be usedto grow a predetermined body part onto that underlying tissue structure.

It is also to be appreciated that surgical fastener 5 can be used toattach bio-compatible inanimate objects to tissue. By way of example,surgical fastener 5 might be used to attach an inanimate device to softtissue. In such a case, the inanimate device can be either absorbable ornon-absorbable. By way of further example, surgical fastener 5 might beused to attach a woven material, or a filament, or a film-like materialto tissue.

Conversely, it is also possible to use surgical fastener 5 to attachtissue to a bio-compatible inanimate object. For example, surgicalfastener 5 might be used to attach a piece of tissue to a bio-compatiblesubstrate, and then that substrate might in turn be attached to anotherpiece of tissue.

Still other variations of this sort will be obvious to a person skilledin the art.

As noted above, the dimensions of surgical fastener 5 will varyaccording to its particular use.

MODIFICATIONS OF THE PREFERRED EMBODIMENTS

It is, of course, possible to modify the preferred embodiments disclosedabove without departing from the scope of the present invention.

Thus, for example, it is possible to provide a surgical fastener 5A suchas that shown in FIG. 30. Surgical fastener 5A is identical to thesurgical fastener 5 disclosed above, except that it has its bar 60A setat a substantially right angle to the axis 15 of its shaft 10.

It is also anticipated that one might provide a surgical fastener 5Bsuch as that shown in FIG. 31. Surgical fastener 5B is identical to thesurgical fastener 5A disclosed above, except that three fins 40 areprovided at the distal tip of the fastener. Alternatively, more thanthree fins might be provided at the distal tip of the fastener.

It is also possible to provide a surgical fastener 5C such as that shownin FIG. 32. Surgical fastener 5C is identical to the surgical fastener5A disclosed above, except that only one fin 40 is provided at thedistal tip of the fastener.

Of course, fins 40 may have other shapes and/or sizes so as to beappropriate for particular tissue attachment procedures.

It is also anticipated that one might provide a surgical fastener 5Dsuch as that shown in FIG. 33. Surgical fastener 5D is identical to thesurgical fastener 5B disclosed above, except that the fastener's bar 60Dincludes a distally projecting portion 60D′ which extends parallel tothe fastener's shaft 10. Thus, fastener 5D is essentially provided witha hook-shaped rear end, where that hook is formed by the proximal end ofshaft 10, bar 60D, and return 60D′.

It is, of course, possible to provide the fasteners 5A and 5C withsimilar hook-shaped rear ends. Thus, for example, a fastener 5E is shownin FIG. 34, where fastener 5E is identical to fastener 5C shown in FIG.32, except that fastener 5E includes a hook-shaped rear end of the sortdisclosed above, i.e., a hook formed by the proximal portion of shaft10, bar 60E and return 60E′.

By providing a hook-shaped rear end on the surgical fastener, it ispossible to attach objects to tissue using the fastener's hook-shapedrear end. By way of example, but not limitation, it is possible to use afastener such as the fastener 5E to attach a piece of surgical mesh totissue, e.g., to abdominal tissue. More particularly, and looking now atFIGS. 35 and 36, in this situation a surgical fastener 5E is set so thatits hook-shaped rear end captures a filament 220 of the surgical mesh225 to tissue 230, with the filament being captured by the hook formedby the proximal end of fastener shaft 10, bar 60E and return 60E′.

Surgical fastener 5E might also be used to attach other objects totissue, e.g., to capture a single long strand or filament to tissue.

It is also anticipated that, in certain circumstances, installation tool75 or second installation tool 150 might be provided with a particulargeometry to facilitate applying the fastener in hard-to-reach places. Byway of example, in FIGS. 4-12, installation tool 5 is shown to have asubstantially straight distal end; and in FIGS. 17-19 and 21-27, secondinstallation tool 150 is shown to have a simple curve at its distal end.However, certain situations may call for a more complex shaft geometryto permit the distal end of the installation tool to reach a particularlocation. For example, and looking now at FIGS. 37 and 38, it isanticipated that one might form the second installation tool 150 so thatit has an elongated tube 190A which includes compound curves. Suchcompound curves can prove exceedingly useful in navigating aroundvarious anatomical structures found within the body, e.g., in navigatingaround the condyles when closing a tear in a piece of meniscal cartilagewithin the knee joint.

It is also possible to form a staple-type of fastener out of two or moresurgical fasteners of the sort disclosed above. Thus, for example, andlooking now at FIGS. 39 and 40, a staple-type surgical fastener 240 canbe formed out of two fasteners 5C of the sort disclosed above. In thissituation, a bridge section 60C″ extends between the two bars 60C so asto link the two fasteners 5C together. A modified installation tool 245,formed out of two installation tools 75 connected together in ways wellknown in the art (not shown), is used to insert the staple-type surgicalfastener 240.

Yet another possible variation is shown in FIG. 41. Here two surgicalfasteners 5A are combined so as to form a staple-type fastener 250. Thisis done by turning each of the surgical fasteners on its side so thattheir surfaces 20 face each other, extending the bar of each fastener,and then joining the two bars together so as to form a bridge 255. Inthis situation, the staple-type fastener 250 can be set by a modifiedinstallation tool 260. Installation tool 260 comprises two installationtools 75 of the sort described above, wherein the installation tools areturned on their sides so that their slots 125 face one another, and thenconnected together in ways well known in the art (not shown).

FIG. 42 shows the staple-like fastener 250 closing a tear 130 in a pieceof meniscal cartilage 135.

FIG. 43 shows another surgical fastener 5F. Surgical fastener 5F isidentical to the surgical fastener 5 described above, except that (i)the fastener's bar 60F extends on both sides of the fastener's shaft10F, and (ii) shaft 10F has its proximal portion 10F′ laterallydisplaced from its distal portion 10F″, so that the fastener's surface265 is coplanar with its surface 25F. Such lateral displacement of shaft10F at the proximal end of the shaft permits fastener 5F to fit ininserter 80, with surfaces 25F and 265 resting on inserter surface 110(FIGS. 4 and 5).

FIG. 44 shows yet another surgical fastener 5G. Fastener 5G is similarto fastener 5A, except that the fastener's bar 60G extends on both sidesof the fastener's shaft 10. In order to install fastener 5G in tissue,it is desirable to use an installation tool comprising an inserter 80G(FIG. 45). Inserter 80G is identical to the inserter 80 described above,except that the inserter has an elliptical cross-section, and a bottomgroove 270 is disposed in the bottom surface of recess 105. Groove 270accepts the lower portion of bar 60G.

Still another surgical fastener 5H is shown in FIG. 46. Surgicalfastener 5H is identical to the fastener 5G described above, except thatbar 60G has been replaced with a relatively large round ball 60H. Itwill be appreciated that fastener 60G can be deployed into tissue usingan inserter very similar to the inserter 80G shown in FIG. 45, exceptthat the bottom groove 270 of inserter 80G would be modified so as tomatch the lower half of round ball 60H.

Further, while in foregoing description and drawings the surgicalfastener's shaft is disclosed as having a round cross-section, othercross-sections (e.g., square or rectangular) could also be used, so longas the carrier portion of that fastener's installation tool is providedwith a corresponding cross-section.

It is also to be appreciated that the present invention has utility innon-medical applications as well. Thus, for example, any one of thefasteners 5, 5A, 5B, 5C, 5D, 5E, 5F, 5G, 5H, 240 and/or 250 could beused in a non-medical setting to attach one object to another object.For example, such a fastener might be used to attach a piece of fabricto a cushion, or a planar sheet to substrate, etc.

Still other embodiments and uses of the present invention will beobvious to a person skilled in the art without departing from the scopeof the present invention.

It is also to be understood that the present invention is by no meanslimited to the particular constructions disclosed herein and/or shown inthe drawings, but also comprises any other modification, changes orequivalents within the scope of the claims.

ADVANTAGES OF THE INVENTION

Numerous advantages are obtained through the provision and use of thepresent invention.

For one thing, a novel surgical fastening system is provided forattaching one piece of tissue to another piece of tissue, wherein thenovel surgical fastening system overcomes the various deficienciesassociated with prior art surgical fastening systems.

For another thing, a novel surgical fastener is provided for attachingone piece of tissue to another piece of tissue.

And a novel installation tool is provided for deploying theaforementioned surgical fastener in tissue.

Also, a novel surgical fastening system is provided which isparticularly well suited for use in repairing tears in meniscalcartilage.

And a novel surgical fastener is provided which is particularly wellsuited for use in repairing tears in meniscal cartilage.

Furthermore, a novel installation tool is provided which is particularlywell suited for use in deploying the aforementioned surgical fastener inmeniscal cartilage.

And a novel method is provided for fastening one piece of tissue toanother piece of tissue.

And a novel method is provided for repairing tears in meniscalcartilage.

Still other advantages will be apparent to those skilled in the art.

1. A method for closing an opening in a tissue, the method comprisingthe steps of: providing a surgical fastener comprising: a shaft; a barextending radially outwardly from a proximal end of said shaft; a finextending radially outwardly from said shaft proximate a distal end ofsaid shaft, said bar and said fin being in alignment with each otheralong a side of said shaft; and providing a holder for said fastener,said holder having disposed therein an opening for retaining saidfastener, and an entry way for receiving an installation tool having acarrier portion thereon adapted to receive and retain said fastener,said carrier portion having cutting means thereon; said entry way andopening being configured to guide said installation tool carrier portioninto engagement with said fastener; whereby upon withdrawal of saidinstallation tool from said holder, said fastener is removed from saidholder and is engaged with said installation tool carrier portion;providing an installation tool comprising: an elongated rigid tube,having at a distal end thereof a carrier portion, said carrier portionbeing movable between a first position in said tube and a secondposition extended from a distal end of said tube, said carrier portionhaving an open side from which extend end portions of said bar and saidfin; and control means for moving said carrier portion and said fastenertherein into a body of tissue, and to withdraw said carrier portion fromsaid tissue; inserting said carrier portion of said installation toolinto said holder opening and withdrawing said installation tool fromsaid holder with said fastener engaged with said installation toolcarrier portion; placing said distal end of said tube adjacent thetissue and proximate the opening in the tissue; manipulating saidinstallation tool control means to move said carrier portion distallyout of said tube and into the tissue until said fastener bar engagessaid tissue; and manipulating said installation tool control means tomove said carrier portion proximally into said tube, whereby to causewithdrawal of said carrier portion, whereupon said fin resistswithdrawal of said fastener and said fastener remains in said tissue assaid installation tool is withdrawn therefrom, to leave said fastener inthe tissue.
 2. A method for attaching a first object to a second object,the method comprising the steps of: providing a surgical fastenercomprising: a solid shaft of substantially uniform diameter having adistal end and a proximal end; a bar at said proximal end of said shaft,said bar extending outwardly from said shaft; said distal end of saidshaft being rounded and devoid of a cutting edge and devoid of apenetration point; and a fin extending outwardly from said shaftproximate said distal end, said fin having a distal edge inclinedoutwardly and proximally from said shaft and a proximal edge inclinedoutwardly and proximally from said shaft; providing an installation toolfor housing said fastener, said installation tool having an open distalend and an open side through which extend said bar and fin of saidfastener, said distal end of said fastener being recessed from saidcutting edge of said installation tool; driving said installation tool,with said fastener therein, through said first object and into saidsecond object until said fastener bar engages a surface of said firstobject; and withdrawing said installation tool from the second objectand then the first object, whereupon said fin, engaged with said secondobject, resists proximal movement of said fastener, causing saidinstallation tool to withdraw from said fastener, to leave said fastenerlodged in both the second object and the first object, with portions ofthe second object and first object held between said fin and said bar soas to hold said first object to said second object.
 3. The method inaccordance with claim 2 wherein said first object comprises a selectedone of a group consisting of a mesh, a filaments and a piece of tissue.4. The method in accordance with claim 2 wherein said first object andsaid second object both comprise living tissue.
 5. The method inaccordance with claim 4 wherein said first object and said second objectboth comprise meniscal cartilage.
 6. The method in accordance with claim4 wherein said first object and said second object both comprise rotatorcuff tissue.
 7. The method in accordance with claim 2 wherein said firstobject comprises a mesh and said second object comprises living tissue.